Recall Z-2465-2012 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Philips Healthcare Inc.
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
| Date | Sep 27, 2012 (initiated Sep 6, 2012) |
| Status | Terminated |
| Reason | The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down |
| Root cause | Device Design |
| Action | Philips Healthcare sent a Urgent Field Safety Notice dated August 13, 2012, to all affected customers. Notifications began the week of September 6, 2012, for US and Worldwide Customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips field service engineer will Secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (loctite). Further information or support concerning this issue, contact your local Philips representative. 1-800-722-9377. |
| Quantity | 93 Units |
| Distribution | Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982795 | PHILIPS BUCKY VISION Philips Medical Systems, Inc., Nov 24, 1998 |